Edesa News Archive

During the year, the company initiated manufacturing activities for a Phase 2 study of Edesa’s dermatology drug candidate, EB06 (an anti-CXCL10 monoclonal antibody), in patients with moderate-to-severe nonsegmental vitiligo. Edesa anticipates that recruitment will begin by midyear 2026, subject to the completion of clinical-grade drug manufacturing and regulatory approvals. In its respiratory program, Edesa reported that a Phase 3 study of its monoclonal antibody, paridiprubart (EB05), met primary and secondary endpoints with statistical significance. Edesa is currently exploring development and commercialization partnerships for paridiprubart as well as expedited regulatory pathways that may be available in certain jurisdictions.

“Our strategy to advance a high-impact dermatology asset alongside a now-validated respiratory therapeutic is bearing fruit, and we believe Edesa is well positioned for our mission to deliver transformative therapies to patients with high unmet medical needs,” said Par Nijhawan, MD, Chief Executive Officer of Edesa. “With new momentum and data in hand, we are engaging with potential strategic and government partners to seek additional non-dilutive support and collaborative arrangements that advance our programs.”

Edesa’s Chief Financial Officer Peter Weiler reported that financial results for the fiscal year reflected a ramp up in activities for the company’s vitiligo program as well as the completion and close-out of the Phase 3 clinical study of paridiprubart. “This year, we strengthened our balance sheet and extended our Canadian government funding agreement to support manufacturing and development for our respiratory program. Looking ahead, our priorities include executing the Phase 2 vitiligo study, advancing respiratory assets toward partnering and commercialization, expanding manufacturing capacity, and maintaining financial discipline,” he said.

Financial Results for the Fiscal Year Ended September 30, 2025

Total operating expenses increased by $0.9 million to $7.9 million for the year ended September 30, 2025 compared to $7.0 million for the prior year:

• Research and development expenses increased by $0.8 million to $3.7 million for the year ended September 30, 2025 compared to $2.9 million for the prior year primarily due to increased expenses for manufacturing-related activities and other preparations for a planned Phase 2 clinical study of EB06 in vitiligo patients, as well as increased external research expenses related to the completion of a Phase 3 study of paridiprubart (EB05) and drug supply costs for an ongoing U.S. government study of paridiprubart, partially offset by lower spend on other development programs.
• General and administrative expenses increased by $0.1 million to $4.2 million for the year ended September 30, 2025 compared to $4.1 million for the prior year primarily due to an increase in noncash share-based compensation, which was partially offset by a decrease in professional fees.

Total other income decreased by $0.1 million to $0.7 million for the year ended September 30, 2025 compared to $0.8 million for the prior year, primarily due to a decrease in interest income, which was partially offset by an increase in reimbursement funding from the Canadian government’s Strategic Innovation Fund.

For the year ended September 30, 2025, Edesa reported a net loss of $7.2 million, or $1.27 per common share, compared to a net loss of $6.2 million, or $1.93 per common share, for the year ended September 30, 2024.

Working Capital

At September 30, 2025, Edesa had cash and cash equivalents of $10.8 million and working capital of $10.4 million. Subsequent to the fiscal year end, the company received $3.4 million in net proceeds, after deducting sales agent commissions, from common shares sold under an at-the-market offering program.

Calendar

Edesa management plans to participate in one-on-one meetings during JP Morgan week, which begins on January 12, 2026, in San Francisco, California. Attendees interested in meeting with management can request meetings by contacting Edesa at investors@edesabiotech.com.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company developing innovative ways to treat inflammatory and immune-related diseases. Its clinical pipeline is focused on two therapeutic areas: Medical Dermatology and Respiratory. In Medical Dermatology, Edesa is developing EB06, an anti-CXCL10 monoclonal antibody candidate, as a therapy for vitiligo, a common autoimmune disorder that causes skin to lose its color in patches. Its medical dermatology assets also include EB01 (1.0% daniluromer cream), a Phase 3-ready asset developed for use as a potential therapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. The company’s most advanced Respiratory drug candidate is paridiprubart, which is being developed as a potential treatment for Acute Respiratory Distress Syndrome, a life-threatening form of respiratory failure. The paridiprubart program has been the recipient of two funding awards from the Government of Canada to support the further development of this asset, and is currently being evaluated in a U.S. government-funded platform study. Edesa is also pursuing additional uses for paridiprubart in chronic respiratory diseases. Sign up for news alerts. Connect with us on X and LinkedIn.

Edesa Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “will,” “would,” “could,” “should,” “might,” “potential,” or “continue” and variations or similar expressions, including statements related to: anticipated initiation of patient recruitment for a Phase 2 vitiligo study by midyear 2026, subject to manufacturing and regulatory approvals; efforts to pursue development and commercialization partnerships for paridiprubart; potential expedited regulatory pathways; strategic initiatives to secure non-dilutive funding and collaborative arrangements; ongoing priorities such as executing clinical studies, advancing respiratory assets toward partnering and commercialization, expanding manufacturing capacity, and maintaining financial discipline; and the company’s timing and plans regarding its clinical studies in general. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa’s operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa’s product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa’s ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises. Many of these factors that will determine actual results are beyond the company’s ability to control or predict. For a discussion of further risks and uncertainties related to Edesa’s business, please refer to Edesa’s public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements.

• Study met primary and secondary endpoints
• Paridiprubart demonstrated a relative reduction in the risk of death of 25%
• Treatment provided patients with clinically meaningful improvement in survival and recovery
• Paridiprubart exhibited consistent safety and tolerability profile

TORONTO, Oct. 28, 2025 (GLOBE NEWSWIRE) — Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics (HDTs) for immuno-inflammatory diseases, today announced positive results from a Phase 3 study evaluating the company’s drug candidate paridiprubart (EB05) as a treatment for Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure.

The data from the Phase 3 study demonstrated that paridiprubart met primary and secondary endpoints with statistical significance. Paridiprubart led to a clinically significant reduction in mortality through 60 days, as well as a significant reduction in the proportion of patients requiring invasive mechanical ventilation (IMV).

Edesa reported that paridiprubart in the most conservative intention-to-treat (ITT) population met the primary endpoint, demonstrating a statistically significant and clinically meaningful benefit for reduced mortality at 28 days. Patients treated with paridiprubart plus standard of care treatments (SOC) had a lower risk of death (39%) compared to those receiving placebo (52%), representing an absolute improvement in survival of 13% at 28 days with paridiprubart demonstrating a relative reduction in the risk of death of 25% compared to placebo (n=104; p<0.001). A durable survival benefit was also demonstrated at 60 days, with patients treated with paridiprubart plus SOC demonstrating a lower risk of death (46%) compared to those receiving placebo (59%), representing an absolute improvement in survival of 13% with a relative risk reduction of 22% for paridiprubart compared to placebo (n=104; p=0.003). In addition, subjects receiving paridiprubart + SOC demonstrated a 41% higher relative rate of clinical improvement, meaning patients no longer required IMV and/or organ support at Day 28.

The results from a safety population of more than 275 subjects, which included patients enrolled during the interim between the Phase 2 and Phase 3 study, demonstrated that EB05 was generally well-tolerated and consistent with the observed safety profile to date.

Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech, said the Phase 3 data further demonstrate the transformative potential of EB05 to improve survival and ICU hospitalization outcomes. “We are encouraged by these positive Phase 3 results, which demonstrated meaningful improvements in outcomes for patients. These data indicate that paridiprubart provided a consistent and durable effect in patients across all severity groups evaluated. We believe that these findings not only provide important validation of our therapeutic approach but also support paridiprubart’s potential use as a standard of care treatment for ARDS, and potentially chronic respiratory indications as well.”

Paridiprubart is currently being evaluated in the U.S. government’s “Just Breathe” study investigating three novel threat-agnostic therapeutics in hospitalized adult patients with ARDS. Edesa’s paridiprubart development program, including this Phase 3 study and manufacturing scale-up, also receives funding from the Government of Canada’s Strategic Innovation Fund.

The study was managed and all analyses were conducted by JSS Medical Research, an international contract research organization.

Detailed Results

Patients were enrolled from 38 hospitals in the USA, Canada and Colombia. Participants were 18 years or older, receiving IMV with or without additional organ support at the time of hospitalization. They were randomly assigned (1:1) to SOC with paridiprubart (15mg/kg, maximum dose of 1400mg, n=56), or SOC with placebo (n=48). Efficacy outcomes were 28-day and 60-day mortality and proportion of patients with a decrease of ≥ 2 points in the WHO COVID-19 Severity Scale (WCSS) at 28-days. The company opted to discontinue enrollment early for business reasons.

Patient demographics and baseline disease parameters were similar for the two groups with overall mean (SD) age: 52 (20-86) years, female (34%), severe ARDS (55%); moderate ARDS (38%); mild ARDS (5%), antivirals (10%), corticosteroids (44%), immunomodulators (10%), IMV only (36%), IMV with additional organ support (64%), acute kidney injury (26%), sepsis (20%), pneumonia (40%).

The following tables summarize the key results from the truncated Phase 3 study.

Mortality Rate at 28 Days and 60 Days
Multivariate Logistic Regression Derived Risk Differences, 95%CI*

Achievement of ≥2-Point Improvement in WCSS at 28 Days
Multivariate Logistic Regression Derived Risk Differences, 95%CI*

About Paridiprubart

Paridiprubart represents a new class of host directed therapeutics (HDTs) that are designed to modulate the body’s own immune response when confronted with known or unknown public health threats such as novel infectious diseases as well as chemical, biological, radiological, and nuclear incidents. Importantly, HDTs are agnostic to the causal agent and can be stockpiled preemptively to respond to public health emergencies and biodefense. Mechanistically, paridiprubart inhibits toll-like receptor 4 (TLR4), a key immune signaling protein that has been shown to be activated by viruses, bacteria, injury/trauma and in the pathogenesis of chronic autoimmune diseases.

About ARDS

Acute Respiratory Distress Syndrome involves an exaggerated immune response leading to inflammation and injury to the lungs that prevents the lungs from oxygenating blood and ultimately deprives the body of oxygen. For moderate to severe cases, there are currently few recommended treatments other than supplemental oxygen and mechanical ventilation, and mortality rates are high. In addition to virus-induced pneumonia, ARDS can be caused by smoke/chemical inhalation, sepsis, chest injury, and other causes. ARDS accounts for 10% of intensive care unit admissions, representing more than 3 million patients globally each year.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company developing innovative ways to treat inflammatory and immune-related diseases. Its clinical pipeline is focused on two therapeutic areas: Medical Dermatology and Respiratory. In Medical Dermatology, Edesa is developing EB06, an anti-CXCL10 monoclonal antibody candidate, as a therapy for vitiligo, a common autoimmune disorder that causes skin to lose its color in patches. Its medical dermatology assets also include EB01 (1.0% daniluromer cream), a Phase 3-ready asset developed for use as a potential therapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. The company’s most advanced Respiratory drug candidate is EB05 (paridiprubart), which is being evaluated in a U.S. government-funded platform study as a treatment for Acute Respiratory Distress Syndrome, a life-threatening form of respiratory failure. The EB05 program has been the recipient of two funding awards from the Government of Canada to support the further development of this asset. Edesa is also pursuing additional uses for paridiprubart in chronic diseases, such as pulmonary fibrosis. Sign up for news alerts. Connect with us on X and LinkedIn.

Edesa Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “will,” “would,” “could,” “should,” “might,” “potential,” or “continue” and variations or similar expressions, including statements related to: the company’s belief that the Phase 3 data of EB05 presented herein demonstrate the transformative potential of EB05 to improve medical outcomes; the company’s belief that these results demonstrated meaningful improvements in outcomes for patients; the company’s belief that these data indicate that paridiprubart provided a consistent and durable effect in patients across all severity groups evaluate; the company’s belief that these findings not only provide important validation of its therapeutic approach but also support paridiprubart’s potential use as a standard of care treatment for ARDS, and potentially chronic respiratory indications; and the company’s timing and plans regarding its clinical studies in general. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa’s operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa’s product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa’s ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises. Many of these factors that will determine actual results are beyond the company’s ability to control or predict. For a discussion of further risks and uncertainties related to Edesa’s business, please refer to Edesa’s public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements.

During the quarter, the company advanced manufacturing-related activities to support U.S. regulatory approval of a Phase 2 study of Edesa’s drug candidate EB06 (an anti-CXCL10 monoclonal antibody) in patients with moderate-to-severe nonsegmental vitiligo. Edesa anticipates drug manufacturing data for EB06 to be submitted to the U.S. Food and Drug Administration (FDA) for its investigational new drug (IND) application by the end of calendar 2025 based on the current availability of manufacturing slots at third party service providers.

“Our manufacturing plans are moving forward, and we’re energized by the opportunity to bring an innovative immunotherapy like EB06 into an area of high unmet need,” said Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech. “We believe that the favorable safety profile of EB06, and its ability to target the immune system mechanisms impacting both lesional and non-lesional skin, has the potential to make it a preferable option for vitiligo patients – especially for those with lesions on more than 10% of their body surface area or those patients concerned about the safety risks of other treatments.”

Edesa’s Chief Financial Officer Peter Weiler reported that financial results for the quarter and fiscal year-to-date were in line with management expectations and continued to reflect the refocusing of company resources to its vitiligo development program. He noted that increased expenditures for Edesa’s EB06 program were offset by decreased expenses for its EB05 drug candidate as the company benefits from the fully funded U.S. government “Just Breathe” study of EB05 and other host-directed therapeutics in a general ARDS patient population. During the quarter, the government announced that the first randomizations for the platform study were completed.

“We are channeling our operational efforts into regulatory preparation and drug manufacturing of our EB06 candidate with the goal of being in a position to move rapidly into clinical testing,” Mr. Weiler said.

Financial Results for the Three Months Ended June 30, 2025

Total operating expenses for each of the three months ended June 30, 2025 and June 30, 2024 were $1.9 million:

• Research and development expenses were $0.9 million for each of the three months ended June 30, 2025 and June 30, 2024, as an increase in EB06-related expenses for Edesa’s planned Phase 2 vitiligo study was offset by a decrease in external research expenses related to the company’s investigational respiratory drug, EB05 (paridiprubart).

• General and administrative expenses were $1.0 million for each of the three months ended June 30, 2025 and June 30, 2024, as a decrease in salaries and related costs was offset by an increase in noncash share-based compensation and professional service fees.

Total other income decreased by $110,000 to $154,000 for the three months ended June 30, 2025 compared to $264,000 for the same period last year. This decrease was primarily due to a decrease in reimbursement funding from the Canadian government’s Strategic Innovation Fund as well as a decrease in interest income.

For the quarter ended June 30, 2025, Edesa reported a net loss of $1.7 million, or $0.25 per common share, compared to a net loss of $1.7 million, or $0.52 per common share, for the quarter ended June 30, 2024.

Financial Results for the Nine Months Ended June 30, 2025

Total operating expenses decreased by $0.6 million to $5.4 million for the nine months ended June 30, 2025 compared to $6.0 million for the nine months ended June 30, 2024:

• Research and development expenses decreased by $0.4 million to $2.4 million for the nine months ended June 30, 2025 compared to $2.8 million for the same period last year primarily due to a decrease in external research expenses related to EB05 (paridiprubart), which was partially offset by an increase in EB06-related expenses associated with preparations for the planned Phase 2 vitiligo study.

• General and administrative expenses decreased by $0.2 million to $3.0 million for the nine months ended June 30, 2025 compared to $3.2 million for the same period last year primarily due to a decrease in professional service fees and noncash share-based compensation.

Total other income decreased by $0.3 million to $0.5 million for the nine months ended June 30, 2025 compared to $0.8 million for the same period last year, primarily due to a decrease in reimbursement funding from the Canadian government’s Strategic Innovation Fund as well as a decrease in interest income.

For the nine months ended June 30, 2025, Edesa reported a net loss of $5.0 million, or $0.95 per common share, compared to a net loss of $5.2 million, or $1.64 per common share, for the nine months ended June 30, 2024.

Working Capital

At June 30, 2025, Edesa had cash and cash equivalents of $12.4 million and working capital of $12.1 million.

Calendar

Edesa management is scheduled to participate in the Canaccord Genuity 45th Annual Growth Conference being held August 12-13, 2025 in Boston, Mass, and the H.C. Wainwright 27th Annual Global Investment Conference being held September 8-10, 2025 in New York, NY. Attendees interested in meeting with management can request meetings through the conference organizers or by contacting Edesa directly at investors@edesabiotech.com.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company developing innovative ways to treat inflammatory and immune-related diseases. Its clinical pipeline is focused on two therapeutic areas: Medical Dermatology and Respiratory. In Medical Dermatology, Edesa is developing EB06, an anti-CXCL10 monoclonal antibody candidate, as a therapy for vitiligo, a common autoimmune disorder that causes skin to lose its color in patches. Its medical dermatology assets also include EB01 (1.0% daniluromer cream), a Phase 3-ready asset developed for use as a potential therapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. The company’s most advanced Respiratory drug candidate is EB05 (paridiprubart), which is being evaluated in a U.S. government-funded platform study as a treatment for Acute Respiratory Distress Syndrome, a life-threatening form of respiratory failure. The EB05 program has been the recipient of two funding awards from the Government of Canada to support the further development of this asset. Edesa is also pursuing additional uses for paridiprubart in chronic diseases, such as pulmonary fibrosis. Sign up for news alerts. Connect with us on X and LinkedIn.

Edesa Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “will,” “would,” “could,” “should,” “might,” “potential,” or “continue” and variations or similar expressions, including statements related to: the company’s belief that EB06 is an innovative immunotherapy and could provide benefits to an area of high unmet need; the company’s belief that EB06 has a favorable safety profile; the company’s belief that EB06 targets the immune mechanisms impacting both lesional and non-lesional skin, and this feature could make it a preferable option for vitiligo patients – especially for those with lesions on more than 10% of their body surface area or those concerned about the risks of other treatments; the company’s plans to channel its operational efforts into regulatory preparation and drug manufacturing of EB06 candidate with the goal of being in a position to move rapidly into clinical testing; the company’s plans to submit EB06 drug manufacturing data to the FDA IND application by the end of calendar 2025; and the company’s timing and plans regarding its clinical studies in general. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa’s operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa’s product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa’s ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises. Many of these factors that will determine actual results are beyond the company’s ability to control or predict. For a discussion of further risks and uncertainties related to Edesa’s business, please refer to Edesa’s public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements.

TORONTO, May 14, 2025 (GLOBE NEWSWIRE) — Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, today reported financial results for the three and six months ended March 31, 2025 and provided an update on its business.

During the quarter, the company completed a $15 million equity financing from healthcare-focused institutional investors, existing Edesa shareholders and insiders to support the development of the company’s vitiligo drug candidate EB06, anti-CXCL10 monoclonal antibody. The company has subsequently initiated outreach to potential investigators and manufacturing-related activities to support U.S. regulatory approval for a Phase 2 study in moderate-to-severe nonsegmental vitiligo patients.

“The initial steps in the manufacturing of our biological drug are ongoing and we are excited about the potential of a novel immunotherapy like EB06. Vitiligo significantly impacts the lives of millions worldwide, yet there are no approved drugs that address the systemic nature of the disease. We believe we can ultimately change the treatment paradigm in much the same manner that immunotherapies have transformed other systemic autoimmune diseases like psoriasis,” said Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech.

Edesa’s Chief Financial Officer Peter Weiler reported that financial results for the quarter reflected a pivot in operational activity to the company’s vitiligo development program, from its respiratory program. Increased expenditures for the EB06 program were offset by decreased expenses for the EB05 drug candidate as the company benefits from a fully funded government study investigating Edesa’s respiratory drug as a treatment for Acute Respiratory Distress Syndrome (ARDS).

“We are deploying additional resources to manufacturing and preparatory regulatory activities to speed the launch of our upcoming vitiligo study, and we anticipate that related research expenditures will generally track activity in this program,” Mr. Weiler said.

Based on the current availability of manufacturing slots at third party service providers, Edesa reported that the company anticipates drug manufacturing data to be submitted to the U.S. Food and Drug Administration (FDA) for its investigational new drug (IND) application in the second half of calendar 2025. Edesa anticipates topline results could be available within as few as 12 to 18 months following regulatory clearance by the FDA. The planned Phase 2 study is already approved in Canada.

Financial Results for the Three Months Ended March 31, 2025

Total operating expenses decreased by $0.6 million to $1.6 million for the three months ended March 31, 2025 compared to $2.2 million for the three months ended March 31, 2024:

• Research and development expenses decreased by $0.7 million to $0.5 million for the three months ended March 31, 2025 compared to $1.2 million for the same period last year primarily due to decreased external research expenses related to manufacturing the company’s investigational drug, paridiprubart, which were partially offset by an increase in EB06-related expenses for the planned Phase 2 vitiligo study.
• General and administrative expenses increased by $0.2 million to $1.2 million for the three months ended March 31, 2025 compared to $1.0 million for the same period last year primarily due to an increase in salaries and related costs, which were partially offset by a decrease in noncash share-based compensation and professional service fees.

Total other income decreased by $311,000 to $49,000 for the three months ended March 31, 2025 compared to $360,000 for the same period last year. This decrease was primarily due to a decrease in reimbursement funding from the Canadian government’s Strategic Innovation Fund as well as a decrease in interest income.

For the quarter ended March 31, 2025, Edesa reported a net loss of $1.6 million, or $0.30 per common share, compared to a net loss of $1.9 million, or $0.58 per common share, for the quarter ended March 31, 2024.

Financial Results for the Six Months Ended March 31, 2025

Total operating expenses decreased by $0.6 million to $3.5 million for the six months ended March 31, 2025 compared to $4.1 million for the six months ended March 31, 2024:

• Research and development expenses decreased by $0.4 million to $1.5 million for the six months ended March 31, 2025 compared to $1.9 million for the same period last year primarily due to decreased external research expenses related to manufacturing the company’s investigational drug, paridiprubart, which were partially offset by an increase in EB06-related expenses for the planned Phase 2 vitiligo study.
• General and administrative expenses decreased by $0.2 million to $2.0 million for the six months ended March 31, 2025 compared to $2.2 million for the same period last year primarily due to a decrease in noncash share-based compensation and professional service fees, which were partially offset by an increase in salaries and related costs.

Total other income decreased by $208,000 to $331,000 for the six months ended March 31, 2025 compared to $539,000 for the same period last year, primarily due to a decrease in interest income as well as a decrease in reimbursement funding from the Canadian government’s Strategic Innovation Fund.

For the six months ended March 31, 2025, Edesa reported a net loss of $3.2 million, or $0.74 per common share, compared to a net loss of $3.5 million, or $1.12 per common share, for the six months ended March 31, 2024.

Working Capital

At March 31, 2025, Edesa had cash and cash equivalents of $13.9 million and working capital of $13.5 million.

Calendar

Edesa plans to participate in the BIO International Convention being held June 16-19, 2025 in Boston, Mass. Attendees interested in meeting with company representatives can request meetings through the conference organizers or by contacting Edesa directly at investors@edesabiotech.com.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company developing innovative ways to treat inflammatory and immune-related diseases. Its clinical pipeline is focused on two therapeutic areas: Medical Dermatology and Respiratory. In Medical Dermatology, Edesa is developing EB06, an anti-CXCL10 monoclonal antibody candidate, as a therapy for vitiligo, a common autoimmune disorder that causes skin to lose its color in patches. Its medical dermatology assets also include EB01 (1.0% daniluromer cream), a Phase 3-ready asset developed for use as a potential therapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. The company’s most advanced Respiratory drug candidate is EB05 (paridiprubart), which is being evaluated in a U.S. government-funded platform study as a treatment for Acute Respiratory Distress Syndrome, a life-threatening form of respiratory failure. The EB05 program has been the recipient of two funding awards from the Government of Canada to support the further development of this asset. In addition to EB05, Edesa is preparing an investigational new drug application (IND) in the United States for EB07 (paridiprubart) to conduct a future Phase 2 study in patients with pulmonary fibrosis. Sign up for news alerts. Connect with us on X and LinkedIn.

Edesa Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “will,” “would,” “could,” “should,” “might,” “potential,” or “continue” and variations or similar expressions, including statements related to: the company’s plans to seek and receive U.S. regulatory approval for a Phase 2 study of EB06 in moderate-to-severe nonsegmental vitiligo patients; the company’s belief in the transformational potential of a novel immunotherapy like EB06; the company’s belief that it can ultimately change the treatment paradigm for vitiligo in much the same manner that immunotherapies have transformed other systemic autoimmune diseases like psoriasis; the company’s ongoing plans to deploy additional resources to manufacturing, regulatory other preparations to speed the launch of its upcoming vitiligo study; the company’s anticipation that related research expenditures will generally track activity in this program; the company’s plans to submit drug manufacturing data to the FDA IND application in the second half of calendar 2025; Edesa’s anticipation that topline results could be available within as few as 12 to 18 months following regulatory clearance by the FDA; and; and the company’s timing and plans regarding its clinical studies in general. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa’s operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa’s product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa’s ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises. Many of these factors that will determine actual results are beyond the company’s ability to control or predict. For a discussion of further risks and uncertainties related to Edesa’s business, please refer to Edesa’s public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements.

During the quarter, the company advanced its main asset, EB06, an anti-CXCL10 monoclonal antibody candidate being developed for the effective and durable treatment of vitiligo. Preparation for the manufacturing campaign is underway, with data anticipated to be submitted to regulators at the U.S. Food and Drug Administration (FDA) during the middle of 2025. The company intends to pursue an investigational new drug (IND) application for a Phase 2 study in moderate-to-severe nonsegmental vitiligo patients. Edesa anticipates topline results could be available within as few as 12 to 18 months following regulatory clearance by the FDA. Health Canada has previously granted approval to initiate this Phase 2 clinical study. The company also reported recently that the development of its anti-TLR4 drug candidate, EB05 (paridiprubart), is fully funded by the U.S. government in a Phase 2 study investigating novel threat-agnostic host-directed therapeutics. As a result of this trial being sponsored and run by the U.S. government, Edesa can prioritize the development of EB06 as a vitiligo therapy.

“Our goal is to be in a position to rapidly launch our vitiligo clinical trial following regulatory clearance,” said Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech. “Vitiligo significantly impacts the lives of millions worldwide, yet there are no approved drugs that address the systemic nature of the disease. We believe that a targeted immunotherapy, like EB06, that interrupts the disease process on a key point in vitiligo pathogenesis (further downstream from JAK inhibitors) could offer a safe and efficacious treatment.”

Edesa’s Chief Financial Officer Stephen Lemieux reported that financial results for the first quarter of fiscal year 2025 were in line with management’s expectations and benefited from a subsequent equity financing. “With a stronger balance sheet, which includes $15.0 million in gross proceeds raised in our institutional investor-led offering, we believe we are well positioned to advance our vitiligo program toward topline data and fund Edesa’s current operating plan.”

Financial Results for the Three Months Ended December 31, 2024

Total operating expenses were unchanged at $1.9 million for the three months ended December 31, 2024 and December 31, 2023:

• Research and development expenses increased by $0.3 million to $1.0 million for the three months ended December 31, 2024 compared to $0.7 million for the same period last year primarily due to increased external research expenses related to manufacturing the company’s investigational drug, paridiprubart.
• General and administrative expenses decreased by $0.3 million to $0.9 million for the three months ended December 31, 2024 compared to $1.2 million for the same period last year primarily due to a decrease in salaries and related costs, noncash share-based compensation and professional service fees.

Total other income increased by $102,000 to $281,000 for the three months ended December 31, 2024 compared to $179,000 for the same period last year. This increase was primarily due to an increase in reimbursement funding from the Canadian government’s Strategic Innovation Fund, which was partially offset by a decrease in interest income.

For the quarter ended December 31, 2024, Edesa reported a net loss of $1.6 million, or $0.48 per common share, compared to a net loss of $1.7 million, or $0.54 per common share, for the quarter ended December 31, 2023.

Working Capital

At December 31, 2024, Edesa had cash and cash equivalents of $1.6 million and working capital of $0.2 million. Subsequent to the quarter end, the company received $15.0 million in gross proceeds from a private placement of preferred and common shares.

Calendar

Edesa plans to participate in the American Academy of Dermatology Annual Meeting from March 7- 11, 2025, BIO Europe Spring 2025 from March 17-19, 2025, and the H.C. Wainwright Autoimmune & Inflammatory Disease Virtual Conference on March 27, 2025. Attendees interested in meeting with company representatives can request meetings through the conference organizers or by contacting Edesa directly at investors@edesabiotech.com.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company developing innovative ways to treat inflammatory and immune-related diseases. Its clinical pipeline is focused on two therapeutic areas: Medical Dermatology and Respiratory. In Medical Dermatology, Edesa is developing EB06, an anti-CXCL10 monoclonal antibody candidate, as therapy for vitiligo, a common autoimmune disorder that causes skin to lose its color in patches. Its medical dermatology assets also include EB01 (1.0% daniluromer cream), a Phase 3-ready asset developed for use as a potential therapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. The company’s most advanced Respiratory drug candidate is EB05 (paridiprubart), which is being evaluated in a U.S. government-funded platform study as a treatment for Acute Respiratory Distress Syndrome, a life-threatening form of respiratory failure. The EB05 program has been the recipient of two funding awards from the Government of Canada to support the further development of this asset. In addition to EB05, Edesa is preparing an investigational new drug application (IND) in the United States for EB07 (paridiprubart) to conduct a future Phase 2 study in patients with pulmonary fibrosis. Sign up for news alerts. Connect with us on X and LinkedIn.

Edesa Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “will,” “would,” “could,” “should,” “might,” “potential,” or “continue” and variations or similar expressions, including statements related to: the company’s preparations for a manufacturing campaign of its anti- CXCL10 monoclonal antibody candidate with data anticipated to be submitted to regulators at the FDA during the middle of 2025; the company’s plans to submit data from the planned manufacturing campaign will U.S. regulators as part of an IND application for a Phase 2 study in vitiligo patients; the company’s anticipation that topline results could be available within as few as 12 to 18 months following regulatory clearance in the U.S; the company’s plans for future funding to support the vitiligo development program; the company’s plans to redeploy more resources to its vitiligo drug development program; the company’s goal to be in a position to rapidly launch its vitiligo clinical trial following regulatory clearance; the company’s belief that a targeted immunotherapy, like EB06, that interrupts the disease process on a key point in vitiligo pathogenesis (further downstream from JAK inhibitors) could offer a safe and efficacious treatment; the company’s belief that first quarter results were in line with management’s expectations, and benefited from a subsequent equity financing; the company’s belief that with a stronger balance sheet, which includes $15.0 million in gross proceeds raised in February 2025, the company is well positioned to advance its vitiligo program toward topline data and fund Edesa’s current operating plan; and the company’s timing and plans regarding its clinical studies in general. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa’s operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa’s product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa’s ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises. Many of these factors that will determine actual results are beyond the company’s ability to control or predict. For a discussion of further risks and uncertainties related to Edesa’s business, please refer to Edesa’s public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements.